COPD With HyperinflationNCT03531775
Upright MRI in Lung Disease
A study testing Upright MRI in people with COPD With Hyperinflation and Diaphragmatic Weakness, run by University of Nottingham at 2 sites in United Kingdom.
Trial summary
The diaphragm is the main muscle assisting breathing. This study aims to assess the use of MRI in patients with diaphragmatic weakness and patients with Chronic Obstructive Pulmonary Disease (COPD) who have hyperinflation. Read more about this study
- Who is it for?
- Ages 18 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- COPD With Hyperinflation, Diaphragmatic Weakness
- What is being tested?
- Upright MRI
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 2 sitesUnited Kingdom
- Study dates
- 16 Jul 2018to Apr 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- General inclusion criteria:
- Adult - Male or female, aged 18 to 90 years old
- Capacity to give informed consent
- Able to hold their breath for 10 seconds
- Able to understand the requirements of the study and to cooperate with the study procedures
- Cohort-specific inclusion criteria:
Show all 15Show fewer
- Healthy participants
- No reported or diagnosed chronic respiratory disease
- COPD with hyperinflation
- Evidence of airflow obstruction on spirometry - FEV1/FVC < 0.7 and FEV1 <80%. (FEV1 = full expiratory volume in 1 second, FVC = full vital capacity)
- Diagnosis of hyperinflation based on imaging or lung function measures.
- Diaphragm weakness due to non-neuromuscular disease
- Established diagnosis of diaphragm weakness due to non-neuromuscular disease, e.g. viral illness, trauma.
- Diaphragm weakness due to neuromuscular disease
- Established diagnosis of diaphragm weakness due to neuromuscular disease
Who cannot join
- Unsuitable for MRI scanning (e.g. have metal implants/pacemaker or contraindicated following questionnaire)
- Deemed unlikely to comply with instructions during imaging
- Deemed not fit enough to tolerate procedure
- Deemed unsuitable by clinical investigator for other reasons
- History of lung volume reduction procedure
Trial locations and contacts
2 sites in 1 country.
United Kingdom2 sites, 2 recruiting
- Recruiting
Nottingham University Hospitals NHS Trust
Nottingham, NG7 2UH
Shahideh Safavi, 00441158231154, shahideh.safavi@nottingham.ac.uk
- Recruiting
University of Nottingham
Nottingham, NG7 2UH
Shahideh Safavi, 00441158231154, shahideh.safavi@nottingham.ac.uk
About this study
Official title: Upright Magnetic Resonance Imaging in COPD and Diaphragm Disease
The diaphragm is the main muscle assisting breathing. This study aims to assess the use of MRI in patients with diaphragmatic weakness and patients with Chronic Obstructive Pulmonary Disease (COPD) who have hyperinflation. In some patients with COPD, air gets trapped in the lungs and causes them to expand too much; this is called hyperinflation. These patient report severe breathlessness, which may be in part because of their diaphragm. It is known that posture impacts lung function and breathing and the investigators want to assess the effect of posture on the diaphragm. Currently, lung function tests and CT or ultrasound scan are the main tests used to check how the diaphragm works. Recently, at University of Nottingham, an new imaging approach has been developed that uses an upright MRI allowing testing the patients in lying position and seated/standing in the same scanner. This may help researchers test the diaphragm position and shape more accurately and check the effects of posture on the diaphragm. This may help researchers and clinicians better understand the relationship between postural changes in diaphragm position and shape and symptoms.
The study will take place at the clinical research MRI centre at Nottingham Medical School, which is next to Queen's Medical Centre. The investigators want to recruit healthy volunteers, patients with diaphragmatic weakness and patients with COPD whose lungs are hyperinflated. The study will last 2 years, and the participants are asked to attend the imaging centre only once, where they will give consent and will be scanned at the same visit, which is expected to take 2 hours to complete. They will be scanned on two scanners: lying and seated/standing in the new upright scanner and lying in a conventional scanner. The investigators will not use any contrast for imaging, i.e. participants will not be injected with a dye and they will breathe air.
Read the detailed description
This is a single centre, proof of concept clinical trial. The investigators want to recruit healthy volunteers, patients with diaphragmatic weakness and patients with COPD whose lungs are hyperinflated. Half the investigators are clinicians and have asked their patient whether such a study would interest them, and patients have been very supportive. This study addresses an unanswered clinical question.
The participants will be adults, men and women, who can give informed consent, and can cooperate with the study procedures. As the participants will be scanned using MRI, people who are unsuitable for MRI scanning, for example those with a pacemaker, will be excluded from the study for safety reasons.The participant will be observed by a clinical investigator throughout the study visit.
As for side effects / risks, no medicinal products will be administered in this study. Some participants may experience anxiety while undergoing MRI scan. It is expected that some patients may not be able to lie flat in the scanner, in which case they will be asked only to undergo scans that they are able to tolerate.
In addition to being scanned using an upright MRI and a conventional MRI, the following measurements will be takes: weight, height, blood pressure, heart rate, oxygen saturation, respiratory rate, and spirometry. The participants will be asked to fill a St George's Respiratory Questionnaire and an MRC (Medical Research Council) Dyspnoea Scale. A detailed medical history will be taken.
The participants will be assigned unique codes, and their data will be anonymised. Participants' medical reports will only be accessed for study purposes and will be treated as confidential.
The investigators will aim to use the data to plan future studies, and the data from this study may contribute to publications and presentations. Participants will not be identified in any publications arising from the research. The data obtained will be published without any identifying information..
- Conditions
- COPD With Hyperinflation, Diaphragmatic Weakness
- Being tested
- Upright MRI
- Keywords
- upright MRI, COPD with hyperinflation, Diaphragmatic weakness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Upright MRIDiagnostic test
Participants will be scanned using an upright MRI in sitting/standing position and supine position. They will also be scanned in supine position using a conventional MRI.
| Study group | Role | What they receive |
|---|---|---|
| Upright MRI | Other | All participants will be scanned using an upright MRI in seated/standing position and supine position. They will also be scanned supine using a conventional MRI. Receives: Diagnostic Test: Upright MRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
The diaphragm will be imaged using MRI in horizontal and vertical positions.
Images will be anonymised and stored securely on University servers.
Measured: 2 years
The change in diaphragm position and morphology on MRI following a change in posture (vertical to horizontal position or vice versa) will be measured.
Measured: 2 years
The diaphragm position and morphology in COPD patients with hyperinflation will be imaged using MRI.
Measured: 2 years
The diaphragm position and morphology in patients known to have diaphragmatic weakness will be imaged using MRI.
Measured: 2 years
Secondary outcomes (2)
The lung function abnormality will be compared with abnormalities in diaphragm position and morphology as noted on MRI.
Measured: 2 years
The patients' symptoms, as reported on St George's Respiratory Questionnaire and a visual analogue scale for breathlessness, will be compared to the abnormalities noted in diaphragm position and morphology on MRI.
Participants will be asked to fill St George's Respiratory questionnaire and a visual analogue scale for breathlessness to assess symptoms.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2018
- Study start16 Jul 2018 (estimated)
- Primary completionApr 2020 (estimated)
- Study completionApr 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COPD With HyperinflationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Clinical trial to study a novel intervention (upright MRI) to compare interventions in clinical practice
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Nottingham
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shahideh Safavi, University of Nottingham
- Investigators
- Shahideh Safavi, Principal investigator, University of Nottingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03531775
- Sponsor's protocol ID
- 18011
- Status last verified
- Jul 2018
- First submitted
- 27 Apr 2018
- Last updated
- 17 Jul 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Upright Magnetic Resonance Imaging in COPD and Diaphragm Disease
- ClinicalTrials.gov ID
- NCT03531775
- Acronym / sponsor ID
- 18011
- Conditions
- COPD With Hyperinflation, Diaphragmatic Weakness
- Keywords
- upright MRI, COPD with hyperinflation, Diaphragmatic weakness
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- University of NottinghamUniversity, hospital or other
- Study start
- 16 Jul 2018 (estimated)
- Primary completion
- Apr 2020 (estimated)
- Study completion
- Apr 2020 (estimated)
- First posted
- 22 May 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The diaphragm is the main muscle assisting breathing. This study aims to assess the use of MRI in patients with diaphragmatic weakness and patients with Chronic Obstructive Pulmonary Disease (COPD) who have hyperinflation. In some patients with COPD, air gets trapped in the lungs and causes them to expand too much; this is called hyperinflation. These patient report severe breathlessness, which may be in part because of their diaphragm. It is known that posture impacts lung function and breathing and the investigators want to assess the effect of posture on the diaphragm. Currently, lung function tests and CT or ultrasound scan are the main tests used to check how the diaphragm works. Recently, at University of Nottingham, an new imaging approach has been developed that uses an upright MRI allowing testing the patients in lying position and seated/standing in the same scanner. This may help researchers test the diaphragm position and shape more accurately and check the effects of posture on the diaphragm. This may help researchers and clinicians better understand the relationship between postural changes in diaphragm position and shape and symptoms.
The study will take place at the clinical research MRI centre at Nottingham Medical School, which is next to Queen's Medical Centre. The investigators want to recruit healthy volunteers, patients with diaphragmatic weakness and patients with COPD whose lungs are hyperinflated. The study will last 2 years, and the participants are asked to attend the imaging centre only once, where they will give consent and will be scanned at the same visit, which is expected to take 2 hours to complete. They will be scanned on two scanners: lying and seated/standing in the new upright scanner and lying in a conventional scanner. The investigators will not use any contrast for imaging, i.e. participants will not be injected with a dye and they will breathe air.
Detailed description
This is a single centre, proof of concept clinical trial. The investigators want to recruit healthy volunteers, patients with diaphragmatic weakness and patients with COPD whose lungs are hyperinflated. Half the investigators are clinicians and have asked their patient whether such a study would interest them, and patients have been very supportive. This study addresses an unanswered clinical question.
The participants will be adults, men and women, who can give informed consent, and can cooperate with the study procedures. As the participants will be scanned using MRI, people who are unsuitable for MRI scanning, for example those with a pacemaker, will be excluded from the study for safety reasons.The participant will be observed by a clinical investigator throughout the study visit.
As for side effects / risks, no medicinal products will be administered in this study. Some participants may experience anxiety while undergoing MRI scan. It is expected that some patients may not be able to lie flat in the scanner, in which case they will be asked only to undergo scans that they are able to tolerate.
In addition to being scanned using an upright MRI and a conventional MRI, the following measurements will be takes: weight, height, blood pressure, heart rate, oxygen saturation, respiratory rate, and spirometry. The participants will be asked to fill a St George's Respiratory Questionnaire and an MRC (Medical Research Council) Dyspnoea Scale. A detailed medical history will be taken.
The participants will be assigned unique codes, and their data will be anonymised. Participants' medical reports will only be accessed for study purposes and will be treated as confidential.
The investigators will aim to use the data to plan future studies, and the data from this study may contribute to publications and presentations. Participants will not be identified in any publications arising from the research. The data obtained will be published without any identifying information..
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Clinical trial to study a novel intervention (upright MRI) to compare interventions in clinical practice
| Arm | Type | Receives |
|---|---|---|
| Upright MRI | Other | Diagnostic Test: Upright MRIAll participants will be scanned using an upright MRI in seated/standing position and supine position. They will also be scanned supine using a conventional MRI. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- General inclusion criteria:
- Cohort-specific inclusion criteria:
- Healthy participants
- No reported or diagnosed chronic respiratory disease
- COPD with hyperinflation
Key exclusion criteria (5 listed)
- Unsuitable for MRI scanning (e.g. have metal implants/pacemaker or contraindicated following questionnaire)
- Deemed unlikely to comply with instructions during imaging
- Deemed not fit enough to tolerate procedure
- Deemed unsuitable by clinical investigator for other reasons
- History of lung volume reduction procedure
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Upright MRIParticipants will be scanned using an upright MRI in sitting/standing position and supine position. They will also be scanned in supine position using a conventional MRI. | Diagnostic test | Upright MRI |
Primary outcome
The diaphragm will be imaged using MRI in horizontal and vertical positions.
Time frame: 2 years
Images will be anonymised and stored securely on University servers.
The change in diaphragm position and morphology on MRI following a change in posture (vertical to horizontal position or vice versa) will be measured.
Time frame: 2 years
The diaphragm position and morphology in COPD patients with hyperinflation will be imaged using MRI.
Time frame: 2 years
The diaphragm position and morphology in patients known to have diaphragmatic weakness will be imaged using MRI.
Time frame: 2 years
2 secondary outcomes
The lung function abnormality will be compared with abnormalities in diaphragm position and morphology as noted on MRI.
Time frame: 2 years
The patients' symptoms, as reported on St George's Respiratory Questionnaire and a visual analogue scale for breathlessness, will be compared to the abnormalities noted in diaphragm position and morphology on MRI.
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shahideh Safavi principal investigator
University of Nottingham
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Upright MRI in people with COPD With Hyperinflation and Diaphragmatic Weakness, run by University of Nottingham at 2 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Shahideh Safavi (00441158231154, shahideh.safavi@nottingham.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The diaphragm will be imaged using MRI in horizontal and vertical positions. (time frame: 2 years). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jul 2018.